Executive Summary / Key Takeaways

• Anixa Biosciences (NASDAQ:ANIX) has strategically transformed into a clinical-stage biotechnology company, focusing on innovative oncology therapeutics and vaccines for critical unmet needs, moving beyond its legacy patent licensing operations.
• The company's pipeline features a novel CAR-T therapy for ovarian cancer, demonstrating a positive safety profile and anecdotal signs of efficacy in Phase 1, and a breast cancer vaccine showing promising antigen-specific immune responses in a completed Phase 1 trial.
• Anixa employs a capital-efficient, collaborative development model, leveraging partnerships with institutions like Moffitt Cancer Center, Cleveland Clinic, NCI's PREVENT program, and VERDI Solutions, which significantly de-risks its R&D efforts.
• Despite being pre-revenue from its core programs, Anixa maintains a solid liquidity position, with approximately $16.03 million in cash, cash equivalents, and short-term investments as of July 31, 2025, projected to fund operations for "significantly longer than 12 months".
• Upcoming catalysts include final Phase 1 breast cancer vaccine data in December 2025 and the initiation of a Phase 2 trial, alongside continued progress in its ovarian cancer CAR-T and new vaccine discovery programs.

A Strategic Pivot Towards Oncology Innovation

Anixa Biosciences has undergone a profound transformation, evolving from its origins as ITUS Corporation in 1982, primarily engaged in technology licensing, to a focused biotechnology entity dedicated to addressing critical unmet needs in oncology. This strategic pivot, formalized with its name change in October 2018, underscores a commitment to developing groundbreaking therapies and vaccines for cancer. The company's overarching strategy centers on a capital-efficient, collaborative model, partnering with leading research institutions to advance its pipeline, with the ultimate goal of licensing its technologies to large pharmaceutical companies for broader market reach. This approach allows Anixa to concentrate on early-stage innovation while mitigating the substantial financial burdens typically associated with late-stage drug development and commercialization.

The biotechnology industry, particularly oncology, is characterized by intense competition, high R&D costs, and stringent regulatory hurdles. Anixa operates within this dynamic landscape, positioning itself as a niche innovator with a focus on highly differentiated technologies. While larger pharmaceutical companies like Bristol-Myers Squibb (BMY), Gilead Sciences (GILD), Moderna (MRNA), and Merck (MRK) command significant market share with diversified portfolios and robust financial resources, Anixa's strength lies in its targeted approach to specific, challenging cancer indications. This focused strategy, coupled with a growing intellectual property portfolio, forms the bedrock of its competitive moat.

Technological Edge: Anixa's Differentiated Pipeline

Anixa's investment thesis is deeply rooted in its innovative technological platforms, which are designed to offer tangible benefits over existing treatments. The company's pipeline is bifurcated into a CAR-T therapeutics program and multiple vaccine programs, each leveraging distinct scientific mechanisms.

Chimeric Endocrine Receptor-T Cell (CER-T) Therapy for Ovarian Cancer

At the forefront of Anixa's therapeutic efforts is its chimeric endocrine receptor-T cell (CER-T) therapy, a novel form of CAR-T technology, initially targeting recurrent epithelial ovarian cancer. This program, developed through its subsidiary Certainty Therapeutics, Inc., holds an exclusive worldwide, royalty-bearing license from The Wistar Institute. The technology aims to harness the body's immune system to specifically target and eliminate cancer cells.

The ongoing Phase 1 clinical trial, conducted in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc., is a dose-escalation study evaluating both intraperitoneal and intravenous delivery methods. The trial has progressed through four dose cohorts, with the latest cohort receiving a dose 30 times higher than the initial cohort. Crucially, the treatment has consistently "appear[ed] to have been well-tolerated" across all dose levels, with "no dose limiting toxicities, cytokine release syndrome or immune effector cell-associated neurotoxicity" observed. While the initial three cohorts were expected to be sub-therapeutic, "multiple patients have exhibited anecdotal signs of efficacy, including possible signs of T cell infiltration and tumor necrosis". Notably, "many patients have survived beyond expectations," with one patient "still alive two years past initial treatment" and another surviving "over one year past treatment". The FDA even approved re-dosing for a patient showing encouraging initial results, with the second treatment administered in October 2024 also appearing "well-tolerated". This sustained tolerability and early anecdotal efficacy in a difficult-to-treat cancer highlight the potential of this differentiated CAR-T platform. Anixa has also strengthened its intellectual property, securing additional U.S. patents for its CAR-T technology in April and August 2025, extending protection to 2045. This robust IP portfolio provides a long-term competitive advantage, safeguarding future licensing opportunities.

Cancer Vaccine Programs: Breast and Ovarian Cancer

Anixa's vaccine pipeline is equally compelling, focusing on preventive and therapeutic approaches. The breast cancer vaccine, developed under an exclusive worldwide license from Cleveland Clinic, targets triple-negative breast cancer (TNBC), the most lethal form of breast cancer. The vaccine targets the α-lactalbumin protein, which is typically only expressed during lactation in healthy tissue but reappears in many forms of breast cancer, particularly TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.

The Phase 1 clinical trial for the breast cancer vaccine, fully funded by a U.S. Department of Defense grant to Cleveland Clinic, has completed enrollment and treatment across three segments: early-stage TNBC patients at high risk of recurrence, healthy individuals with high-risk genetic mutations (BRCA1/2 or PALB2), and post-operative TNBC patients with residual disease undergoing pembrolizumab (Keytruda) treatment. Data presented in December 2023 revealed "various levels of antigen-specific T cell responses were observed at all dose levels" in vaccinated women. Further data in November 2024 confirmed "antigen-specific immune responses at all dose levels and in all three patient groups" and, critically, "no adverse side effects were seen other than varying degrees of injection site irritation". Patients receiving the vaccine in combination with Keytruda also showed "no additional or more severe adverse side effects". These results are highly promising, indicating a well-tolerated vaccine that elicits a targeted immune response. Anixa anticipates reporting final Phase 1 data in December 2025 and is preparing to initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to assess its therapeutic effect. The company has also secured significant international intellectual property, with notices of allowance for breast cancer vaccine patents in the U.S. (July 2025), Canada (July 2025), and China (August 2025), extending protection into the 2040s and addressing a "multi-billion dollar market potential".

The ovarian cancer vaccine program, also licensed from Cleveland Clinic, targets the AMHR2-ED protein, which is highly expressed in postmenopausal women with ovarian cancer. This program benefits significantly from its acceptance into the National Cancer Institute's (NCI) PREVENT program in May 2021. The NCI is providing "scientific and financial resources" for virtually all preclinical research and development, manufacturing, and IND-enabling studies, requiring "no material financial expenditures by the Company". This collaboration provides substantial non-dilutive funding and scientific validation, accelerating development while conserving Anixa's capital.

Beyond these core programs, Anixa is actively expanding its pipeline. In May 2024, it entered a Joint Development and Option Agreement with Cleveland Clinic to discover additional "retired proteins" for new cancer vaccines targeting high-incidence malignancies in the lung, colon, and prostate. Furthermore, a letter of intent with VERDI Solutions, GmbH, in March 2025, aims to develop AI-guided personalized and off-the-shelf peptide vaccines, leveraging VERDI's demonstrated safety and efficacy in cancer patients. These initiatives underscore Anixa's commitment to continuous innovation and pipeline diversification, leveraging its core scientific mechanism and embracing cutting-edge approaches like AI.

Strategic Collaborations and Competitive Positioning

Anixa's business model is inherently collaborative, a strategic choice that allows it to compete effectively against larger, more resource-rich pharmaceutical companies. By partnering with academic institutions and government programs, Anixa gains access to world-class scientific expertise, clinical trial infrastructure, and non-dilutive funding, significantly reducing its operational burn rate and accelerating development timelines. This approach is a key differentiator against competitors like Bristol-Myers Squibb and Merck, which rely heavily on their vast internal R&D budgets and established commercial infrastructures.

While Anixa's scale is smaller, its agility and specialized focus enable it to pursue niche, high-unmet-need indications that might be overlooked or deprioritized by larger players. For instance, its targeted CAR-T for ovarian cancer and preventive vaccine for TNBC address specific patient populations with limited effective options. This contrasts with the broader, more diversified portfolios of companies like Gilead Sciences, which has a strong presence in antivirals and expanding oncology, or Moderna, a leader in mRNA platforms with broad applicability. Anixa's technological advantages, such as the unique mechanism of its cancer vaccines and the novel CER-T approach, provide a strong foundation for differentiation. The extensive patent protection secured for both its CAR-T and breast cancer vaccine technologies further solidifies its competitive moat, creating significant barriers to entry for potential rivals.

The biotechnology sector faces high barriers to entry, including substantial R&D costs, complex regulatory pathways, and the need for specialized scientific and clinical expertise. Anixa's collaborative model effectively addresses these challenges, allowing it to leverage external resources to overcome these hurdles. While the broader industry is seeing trends like increased AI integration in drug discovery, which could raise operational costs, Anixa's partnership with VERDI Solutions for AI-guided vaccines demonstrates its proactive engagement with these advancements, potentially enabling more efficient and targeted development.

Financial Performance and Operational Discipline

As a clinical-stage biotechnology company, Anixa Biosciences has not yet generated revenue from its therapeutic or vaccine programs, a common characteristic in this phase of development. The company's financial performance reflects its significant investment in research and development. For the nine months ended July 31, 2025, Anixa reported a net loss of $8.306 million, an improvement from a net loss of $9.785 million during the same period in 2024. Similarly, the net loss for the three months ended July 31, 2025, decreased to $2.280 million from $3.315 million in the prior year period.

This reduction in net loss is primarily attributable to a decrease in operating expenses. Total operating expenses for the nine months ended July 31, 2025, were $8.825 million, down from $10.668 million in the corresponding period of 2024. Research and development expenses, the largest component of operating costs, decreased by approximately $991,000 to $3.929 million for the nine months ended July 31, 2025, compared to $4.920 million in the prior year. This reduction was mainly driven by lower outside R&D expenses for the breast cancer vaccine (approximately $524,000 decrease) and the ovarian cancer CAR-T therapeutic (approximately $402,000 decrease), alongside reduced employee stock-based compensation. General and administrative expenses also saw a decrease of approximately $852,000 to $4.90 million for the nine months ended July 31, 2025, primarily due to lower investor and public relations expenses, and reduced director and employee stock-based compensation. These trends demonstrate Anixa's operational discipline in managing its burn rate while advancing its pipeline.

Interest income, derived from its cash and short-term investments, decreased to $519,000 for the nine months ended July 31, 2025, from $883,000 in the prior year, primarily due to a decrease in the amount of short-term investments held and a reduction in interest rates.

Liquidity and Capital Strategy

Maintaining a strong liquidity position is paramount for pre-revenue biotechnology companies. As of July 31, 2025, Anixa Biosciences held approximately $1.495 million in cash and cash equivalents and $14.534 million in short-term investments, totaling approximately $16.03 million. This represents a reduction of approximately $3.90 million for the nine months ended July 31, 2025, compared to October 31, 2024. Despite this, management believes that its existing cash, cash equivalents, and short-term investments are sufficient to fund its activities for "at least the next twelve months" and "significantly longer than 12 months" from September 10, 2025.

During the nine months ended July 31, 2025, cash used in operating activities was approximately $5.92 million. The company strategically utilized an at-the-market (ATM) equity offering, raising approximately $1.92 million, net of expenses, through the sale of 611,686 shares of common stock.

As of July 31, 2025, Anixa retains the capacity to sell approximately $95 million of common stock under its currently effective ATM program, providing a flexible avenue for future capital raises if needed. This prudent capital management, combined with its collaborative model that conserves funds, positions Anixa to continue advancing its pipeline without immediate liquidity concerns.

Outlook and Milestones

The near-term outlook for Anixa Biosciences is marked by several significant clinical and operational milestones. The company anticipates reporting final Phase 1 data for its breast cancer vaccine at the San Antonio Breast Cancer Symposium in December 2025. Following these promising Phase 1 findings, Anixa is preparing to initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to determine the vaccine's possible therapeutic effect. The commencement of this Phase 2 trial is contingent on final Phase 1 data release, FDA consultations, protocol development, manufacturing, and clinical site selection.

For its ovarian cancer CAR-T therapy, the Phase 1 clinical trial is estimated to be completed in two to three years, with the timeline dependent on factors such as reaching the maximum tolerated dose, patient enrollment rate, and the significance of efficacy data. The ongoing progress in dose escalation and the observed tolerability and anecdotal efficacy provide a positive trajectory for this program.

Analyst sentiment also reflects a positive shift, with Zacks Equity Research recently upgrading Anixa Biosciences to a Zacks Rank #2 (Buy). This upgrade "reflects an upward trend in earnings estimates" and fundamentally signals "an improvement in the company's underlying business". Analysts expect Anixa to report an EPS of -$0.38 for the fiscal year ending October 2025, representing a year-over-year change of 2.6%, and the Zacks Consensus Estimate has increased by 7.3% over the past three months. These revisions, while still reflecting a loss, indicate a more favorable earnings outlook.

Investment Risks

Investing in clinical-stage biotechnology companies like Anixa Biosciences carries inherent risks. The company has not generated revenue from its core therapeutic and vaccine programs and does not expect to do so in the near term. The eventual commercialization of its technologies is entirely dependent on positive results from human clinical trials and successful licensing agreements, which "may take several years, if it is to occur at all". Clinical trials are complex, costly, and subject to high rates of failure. Any setbacks in trial outcomes, regulatory approvals, or manufacturing could significantly impact the company's prospects.

Furthermore, Anixa's reliance on collaborations, while capital-efficient, introduces dependency on third parties for development and funding. The company also faces intense competition from larger pharmaceutical and biotechnology firms with greater financial and R&D resources. While Anixa's intellectual property portfolio is growing, the enforceability and breadth of patents in the biotechnology space can be subject to challenges. The company's critical accounting policies, particularly those related to revenue recognition, stock-based compensation, and research and development expenses, require "difficult, subjective or complex judgments". Anixa also has substantial net operating loss carryforwards, which "could be subject to limitations under Internal Revenue Code section 382".

Conclusion

Anixa Biosciences stands at a pivotal juncture, having successfully transitioned into a focused oncology biotechnology company with a promising pipeline of differentiated therapies and vaccines. Its strategic emphasis on collaborative development has enabled it to advance novel CAR-T and vaccine platforms for high-unmet-need cancers like ovarian and triple-negative breast cancer, while prudently managing its financial resources. The positive safety and early efficacy signals from its Phase 1 trials, coupled with a robust and expanding intellectual property portfolio, underscore the potential for significant long-term value creation through future licensing agreements.

While the path to commercialization in biotechnology is fraught with challenges and uncertainties, Anixa's disciplined operational execution, strong liquidity position, and upcoming clinical milestones provide a compelling narrative for discerning investors. The company's technological leadership in targeted oncology, supported by strategic partnerships and a clear roadmap for advancing its pipeline, positions it as a compelling, albeit speculative, long-term investment opportunity in the dynamic cancer treatment landscape. Continued progress in its clinical trials and the successful execution of its licensing strategy will be critical determinants of its future success.